Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Ag...
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of July 15, 2019.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Application No.
Drug
Applicant
ANDA 040664
A-Methapred (methylprednisolone sodium succinate) for Injection USP, Equivalent to (EQ) 40 milligrams (mg) base/vial
Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 078815
Oxaliplatin for Injection, 50 mg/vial and 100 mg/vial
Hospira, Inc.
ANDA 088119
Isoniazid Tablets USP, 300 mg
Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pky., Morris Corporate Center III, Parsippany, NJ 07054.
ANDA 088231
Isoniazid Tablets USP, 100 mg
Do.
ANDA 091597
Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ 1 gram base/vial
Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd., Suite 450, Schaumburg, IL 60195.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 15, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on July 15, 2019, may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Use this for formal legal and research references to the published document.
84 FR 27788
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications,” thefederalregister.org (June 14, 2019), https://thefederalregister.org/documents/2019-12560/hospira-inc-et-al-withdrawal-of-approval-of-12-abbreviated-new-drug-applications.
21 CFR 314.150(c)
21 U.S.C. 331(a)